NEW YORK, March 8 (UPI) -- Omrix said Thursday it filed an application with the U.S. Food and Drug Administration seeking an expanded indication for Evicel.
The company's supplemental biological license application seeks approval for using its fibrin sealant Evicel for treating general hemostasis in surgery.
"With the expected approval of this sBLA, Omrix will have the only fibrin sealant in the United States with a general hemostasis indication in surgery," said Robert Taub, the company's president and chief executive officer.
Taub added that if the sBLA is approved, it would enable Omrix's marketing partner Ethicon "to exploit the full potential of this product."
The sBLA is supported by a phase 3 study comparing the hemostasis efficacy of Evicel to the standard of care in 135 patients who underwent retroperitoneal or intra-abdominal surgery.
